Resilience And Healthy Lifestyle for Rheumatoid Arthritis (The RA-HEAL trial): a randomised, parallel group, placebo-controlled clinical trial protocol

Background : The importance of self-management strategies that optimize physical health and mental health in the management of rheumatoid arthritis (RA) is recognized, but access to multidisciplinary teams to support this can be challenging. Furthermore, evidence for the impact of multidisciplinary interventions, especially in early RA, is lacking. Methods : The Resilience and Healthy Lifestyle for Rheumatoid Arthritis (RA-HEAL) Trial is a pragmatic RCT that aims to compare effects of a structured multidisciplinary lifestyle intervention with self-directed activities in best-practice usual care. The 20-week multi-modal intervention incorporates structured resilience training conducted by a clinical health psychologist (CHP), followed by an exercise physiologist (EP)-led exercise program, dietary education conducted by a dietitian nutritionist (DN), smoking cessation program (where applicable) and psychologist-led behavior-change support. The comparison group will receive written information on healthy lifestyle in accordance with standard best practice care. The primary outcome is health-related quality of life (QoL) at 6 months. Discussion : RA-HEAL tests whether a tailored intervention including formal resilience training with a clinical psychologist followed by Mediterranean diet, exercise, smoking cessation and behavior change support has a greater effect on health-related QoL at 6 months, than written advice given in current best-practice settings. QoL is a composite endpoint that is highly valued by patients with RA. RA-HEAL is unique in it targets RA within 12 months of onset. RA-HEAL’s linkage with the Australian Autoimmune Arthritis Biobank Cooperative (A3BC) supports 6 monthly follow-up data and biosampling to 24 months post-intervention and linkage to health data collections, creating a valuable resource for future research and the potential to determine medium and long-term effects of behavior change. In its secondary outcomes, RA-HEAL will analyze the longevity of effects of intervention or best-practice usual care for up to 2 years, and cost utility. The outcomes should provide evidence to underpin a scalable approach to support people with newly-diagnosed RA. Trial registration : ACTRN12625000050459, ANZCTR